System and Apparatus for Medical Error Monitoring

ABSTRACT

An apparatus and system for providing improved monitoring errors in a medical setting. The apparatus includes a storage medium, display and scanner that allow medical personnel to quickly and reliably track and monitor samples collected from patients, such as information about the type, location, and timing of a collected sample. An unable to complete function labels incompletely collected samples or otherwise notifies the processing facility. Label sets and/or messages are generated to guide medical personnel when performing orders. Errors are linked to collection events for variance tracking. Temporary identifier labels are generated for containers and such when no order is pending. Order of draw procedures are communicated to medical personnel at the collection site.

The present application claims the benefit of U.S. ProvisionalApplication No. 60/575,244, filed on May 28, 2004; U.S. ProvisionalApplication No. 60/571,434 filed May 14, 2005 and U.S. ProvisionalApplication 60/566,439 filed on, Apr. 30, 2004 under 35 U.S.C. 119(e).

FIELD OF THE INVENTION

The present invention generally relates to remote networked medicalerror management devices, systems, and methods for using and operatingthe same. In particular, the present invention relates to a remotemedical error management device having functionality to monitor,facilitate, and audit medical services.

BACKGROUND OF THE INVENTION

Laboratory Information Systems (LISs) and Hospital Information Systems(HISs) both fall under the category of Health Care Information orEnterprise Systems. Generally, health care enterprises provide variousaspects of patient care such as patient identification and tracking, aswell as medication and sample collection order and data management. Inproviding patient care, health care workers typically utilize one ormore software applications accessible through a health care informationsystem. Access to health care information systems have typically, in thepast, required fixed terminals such as nurse workstations to be used ata location potentially distant from the point of care (i.e., at thepatient's location). To provide more convenient and efficient access toan LIS, more portable modules such as handheld computers or portabledata terminals (PDTs) have recently been introduced into health care andhospital settings and are hereinafter generally referred to as“handhelds”. The handhelds can be connected to a server directly througha LAN, modem, or wireless connection. Optionally, the handhelds can beconnected to a server through a PC using a serial or parallelconnection. In order to use the handheld, the information on thehandheld is synchronized with the LIS by connecting the handheld to adata import/export device connected with the LIS, or via a cableconnected with the LIS, to allow the exchange of data between the LISand the handheld.

In particular, portable computing devices utilizing software for medicalerror management are becoming increasingly common as medical healthcaretechnology improves. A portable computing device can collect clinicaland non-clinical information about the sample collection process at ahospital, laboratory, or blood collection facility or clinic. To bettermanage patient-related testing results and the specimens from whichthose results were derived from, it is important to track the collectedspecimens and match them to the patient's identification information,which is typically stored in patient and specimen order databases suchas hospital or laboratory information systems.

On occasion, a deviation might occur during the process of collectingsamples from a patient. For instance, while collecting blood samplesinto blood collection containers, it is possible that a vein willcollapse and the nurse or phlebotomist will not be able to collect allof the ordered collection containers that he or she has been instructedto complete. The containers, after being filled with blood samples, aretypically put into a bag (one bag per patient) and subsequentlydelivered through a pneumatic tube system commonly found in hospitals.The pneumatic tube system will deliver the collected samples to thelaboratory where the laboratory personnel gather and organize andsometimes even prioritize the samples for analysis on high-throughputanalyzers.

If there was a problem collecting one of the tests samples ordered, itis the responsibility for the nurse or phlebotomist who performed thecollection to notify the laboratory so that the laboratory personnel canappropriately address the situation. However, this step is oftenoverlooked or forgotten, thereby likely requiring the laboratorytechnician to reorder the test for the same patient and possibly delaythe analysis and results associated with that patient. Theabove-described inefficiency is time consuming and potentially dangerousif the doctor who ordered the tests needs the patient's clinical resultsin a timely fashion. It is also a discomfort to the patient asadditional and potentially unnecessary sample collections are requireddue to lack of proper communication between the medical personnelinvolved in collecting and analyzing a sample. A need therefore existsfor a medical error monitoring and management system that providescommunication channels and/or means to notify a laboratory when lessthan all of the containers for an order are collected.

SUMMARY OF THE INVENTION

The proposed invention allows a hospital or laboratory technician suchas a phlebotomist, doctor, or nurse to improve specimen collection orderfulfillment and medical error monitoring.

An object of the present invention is to provide printed barcode labelsthat may be used to facilitate and complete the collection process andprocessing of medical tests. In accordance with an aspect of the presentinvention, the nurse or phlebotomist scans his or her own ID badge toidentify themselves to the handheld. This part of the sample collectionprocedure is completed prior to the phlebotomist or nurse performing aspecimen collection activity. Barcode scanning the patient along withthe specimen collection containers intended for use facilitates theidentification task associated with the collection processexpeditiously, further reducing the time and inefficiencies associatedwith manually writing labels that are to be applied to containers orpatient charts.

In accordance with another aspect of the present invention, a method isprovided to acknowledge and record an exception event in data collectionand allow an accurate recording and proper communication of an expectedevent that failed to occur. The present invention allows a hospital orlaboratory technician such as a phlebotomist or nurse to quickly andconveniently communicate with a centralized laboratory in a hospital orother laboratory regarding a deviation in the completion of a specimencollection order. A preferred embodiment of the present inventionenables an LIS to easily track and communicate sample collectiondeviations via barcode input or some other information. The basiccomponents of a preferred embodiment of the present invention are aportable medical handheld device and miniature identification codereader. The identification code reader could be a barcode scanner,imager, radio frequency identification (“RFID”), infrared identificationreader or similar technology. An example of such a portable computingdevice is the Symbol Technologies PPT 1800 Series Pocket PC. Thehandheld comprises features that include bar code scanning and real-timewireless communication options.

The subcomponents of the medical handheld device may be a battery,display, keyboard, cradle, wireless communications circuitry, memory,housing, and central processing unit (CPU). The medical handheld devicecan be any portable diagnostic monitor such as a portable data assistant(PDA), notebook computer, tablet PC, or other device. An identificationcode reader can be integrated into the medical handheld device orattached to the medical handheld device via an accessory device. Thereader could potentially be detachable to the portable computing device.

Along with carrying the portable medical computing device, which mayhave a reader attached or integrated inside, a nurse or phlebotomist canalso carry a portable printer for printing barcodes at the site ofpatient sample collection. In a preferred embodiment, blood collectioncontainers are used which include a barcode having tube-specificinformation to be registered with the handheld of the present invention.For example, a plurality of collection containers such as bloodcollection tubes, blood culture bottles, and the like could have atwo-dimensional barcode that provides information about the type ofcollection container such as catalog number, expiration date, andreorder number.

Under certain circumstances, a collection exception event involves anorder with more than one of the same type of container. In accordancewith a further aspect of the present invention, an Unable to CompleteCollection (UTC) feature provides communication of uncollected eventdata from the handheld to a laboratory and the LIS when collection usingone or more of the same type of container is unsuccessful. This featureassists in determining the necessity of collecting additional data ifsuccessful event recordings provide enough information invalidating theneed. In the hospital environment, when a patient blood collection orderhas been introduced to the Laboratory Information System, the ordermight call for identical samples to be collected for additional testingvolume of patient sample. However, if the additional identical samplecould not be collected based on an unexpected situation, i.e. veincollapse, patient refusal to provide draw of blood, other emergency,etc., the proposed invention herein provides a feature to alert thelaboratory personnel of the error. As the laboratory personnel will beinformed about the status of an order whether successful or not, thisfeature will reduce, or in some instances eliminate, poor communicationbetween the clinician and laboratory. Laboratory personnel, uponrecognizing an event exception, can quickly determine if the successfulspecimen collections obtained provide sufficient sample for the requiredtest or tests and appropriately address the situation. Without propercommunication from the clinician, the laboratory personnel might berequired to reorder the entire specimen collection based on incompleteinformation provided, causing analysis delays which leads to treatmentdelays.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, advantages and novel features of the presentinvention will be readily comprehended from the following detaileddescription when read in conjunction with the accompanying drawings:

FIGS. 1, 2, 3 and 4 each illustrate a client handheld(s) and serverconfigured, in accordance with different embodiments of the presentinvention, in use with different configurations of a health careinformation or enterprise system;

FIG. 5 depicts a client handheld configured, in accordance with anembodiment of the present invention, in use with a specimen containerand corresponding bar code label; and

FIGS. 6 through 14 depict respective client handhelds with exemplarydisplay screens, in accordance with an embodiment of the presentinvention;

FIG. 15 is a flow chart depicting a sequence of operations forcontrolling a client handheld(s) when an order cannot be completed inaccordance with an embodiment of the present invention; and

FIGS. 16 through 26 depict different web pages generated by a system webinterface, in accordance with an embodiment of the present invention;

FIGS. 27 through 29 are flow charts depicting different systemarchitectures for systems using the present invention; and

FIG. 30 is a flow chart depicting a sequence of operations for providingthe Temp ID function of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In accordance with the present invention, an error monitoring andmanagement system 10 (FIG. 1) and portable medical device 22 (FIG. 5)are provided. The device 22 uses handheld scanners for specimencollection procedures, similar to those commonly done in hospitals. Forillustrative purposes, the system 10 and device 22 will be describedherein with reference to specimen collection procedures. It is to beunderstood that the system 10 and the devices 22 can also be used formonitoring the administering of therapeutics to patients, among othersimilar applications. The system 10 can be the BD.id system availablefrom Becton Dickinson and Company, Franklin Lakes, N.J.

The handheld or PDT 22 (FIG. 5) allows a user such as a nurse orphlebotomist to match the specimen collection orders stored in thehandheld 22 with the information scanned from the patient wristband, andto confirm that the specimen container 56 is the correct one for thetests ordered. A new bar code label 52 for the specimen container isprinted at the patient's bedside with the time and date of collection.The label can be placed on the collection container, the patient'schart, or both. Additionally, the information about the time and date acontainer is collected can be electronically transmitted to a datastorage element (e.g., the LIS 24 or SMS 20) for retrieval at a latertime. Lastly, when replaced in its cradle 34, the handheld synchronizeswith the SMS 44, which is then able to communicate with the LIS 24.

As will be described in further detail below, one of the features of thesystem 10, in accordance with an embodiment of the present invention,involves communication between the user and the handheld 22 that therehas been a deviation in the order of collection performed by thephlebotomist. This deviation can take a number of different forms. Mostimportantly, a button on a handheld 22 or a portion of the screen on thehandheld 22 are reserved for the user to communicate to the handheldthat the deviation has occurred. With reference to FIGS. 1 through 4,the system 10 preferably comprises a server 20 (e.g., a specimenmanagement server (SMS)), a plurality of client handhelds 22 with dataaccessibility to the server 20, a LIS (Laboratory Information System)24, and an ADT (Admission, Discharge, and Transfer system) 26. Thesystem components are connected to a network 40 to allow for specificcommunication events to occur. Other embodiments might include aspectsof the server 20 embedded into the LIS 24 instead. The handhelds 22 cancommunicate with hospital computer systems (e.g., the LIS, ADT and HIS)via the server 20. Alternatively, the LIS, for example, can beconfigured to communicate directly with the handhelds 22.

To understand the present invention, certain terms shall be defined asfollows:

DEFINITIONS Client

The client 22 is the handheld device that can download files and datafor manipulation, run applications, or request application-basedservices from a file server.

Cradle

A cradle 34 is a docking station used to provide an interface with ahost terminal. The cradle 34 can be adapted to receive and secure thehandheld 22. A detector element can be included to detect when thehandheld 22 is placed in the cradle. Data can be received from a server20 and selectively downloaded when the handheld is placed in the cradle.In one embodiment of the present invention, the server 20 is a SMS. Anactuator on the handheld can be employed for initiating the transfer ofdata to a process in the host terminal if the detector indicates thatthe handheld 22 has been placed in the cradle 34.

Collection Container Label Printer

The collection container label printer 32 is a printer intended forprinting labels at the point of use, such as the location of samplecollection. More specifically, in certain locations within thehealthcare setting, collection container label printers are needed forprinting labels with indicia of the collected sample for downstreamtracking and processing of the sample, such as which patient the samplewas taken from, and other information useful for the healthcare workeror laboratory technician. An important element on the collection labelsis the container number (e.g., barcode), which can generally bedescribed as the collection identification number. Ideally bloodcollection containers 56 (FIG. 5) would be available to the health careworker including a barcode 52 or RFID (radio frequency identification)tag communicating tube specific information to be registered with theportable handheld device 22 of the present invention. In one embodiment,the barcode label 52 is printed upon scanning of a collectioncontainer's barcode after the user and patient have both been scannedinto the system. The barcode printer 32 can be located or housed on aphlebotomy cart or tray, or mounted in a patient's room or the like. Theprinter 32 creates a customized label 52 containing the bar codeaccession number that the LIS 24 has assigned to the specimen. Theprinter 32 may be a portable printer such as a battery-powered thermalprinter.

Database

The term database (e.g., the specimen management database (SMD) 44)includes one or more large structured sets of persistent data, usuallyassociated with software to update, insert, and query the data.

Handheld

The term handheld (e.g., client handheld 22) describes portablecomputers useful for executing specimen or medication management at thepoint of use. An example of such a portable handheld element is theSymbol Technologies PPT 1700 Series handheld. This specific handheld hasIR and barcode scanning capabilities. The handheld comprises a graphicaluser interface (GUI) for displaying information useful for collectingspecimen samples from a patient.

Preferably, the handheld includes a microprocessor, reading element suchas a bar code scanner, and printing element. The reading element iscapable of reading identification information from a patientidentification code and producing a corresponding information label. Themicroprocessor is capable of processing data relating to theidentification information. The handheld ideally comprises a miniatureidentification code reader. The identification code reader could be abarcode scanner, imager, infrared identification reader, RFID reader orsimilar technology. A barcode scanner could be integrated into themedical handheld device or attached to the medical handheld device viaan accessory device. Likewise, an RFID reader could be integrated intothe medical handheld device so that when in the proximity of thecontainer the container's RFID could be read by the reader. The handheldpreferably includes a battery, a display screen for the GUI, depressiblekeys, communication circuitry, a memory element, a housing for securingall the handheld subcomponents, and a microprocessor. The portablehandheld device could be a portable digital assistant (PDA), tablet PC,or notebook computer that includes a module and/or software forcommunicating with a server.

HIS

The Hospital Information System (HIS) 38 (FIG. 2) is a system developedwith the objective of managing and streamlining the treatment flow of apatient in the hospital, along with all data associated with the patientnecessary for efficient and organized healthcare service. Treatment flowincludes, but is not limited to, specimen management and medicationmanagement. The HIS allows doctors and other staff to perform to theirpeak ability in an optimized and efficient manner. Most HISs aremodular, thus ensuring sustained benefits through changes in technologysuch as integration with new and improved LIS and ADT systems 24 and 26.

HISs 38 use a network of computers to gather, process, and retrievepatient care and administrative information for most hospital activitiesto satisfy the functional requirement of the users. HISs also help toprovide decision support systems for hospital authorities developing andmanaging comprehensive health care policies.

HISs 38 incorporate integrated computerized clinical information systemsfor improved hospital administration and patient health care. They alsoprovide for accurate, electronically stored medical records for one ormany patients. Typically, HISs are centralized information systemsdesigned for quick delivery of operational and administrativeinformation and include software capable of optimizing core data andother application modules customizable to the hospital or healthcarefacility.

LIS

The term LIS 24 preferably defines a computer network comprised ofindustry standard network hardware and software (network andcommunication protocols) that serves to allow communication between thepatient health record repository, the end-user client applicationsrunning on various device types, and the various types of servers. Thisnetwork can take the form of a cable-based or fiber optic network, alocal area network (LAN), a wide area network (WAN), a virtual privatenetwork (VPN), the Internet, or any other type of network that allowscommunication between computing devices.

The LIS typically is limited to laboratory information systems thatorganize and track information pertaining to laboratory tasks such ashow orders are generated and communicated to the lab, how patients orsamples are delivered, how the samples are accessioned and prepared, howtesting is actually accomplished, and how results are communicated tohealthcare providers. LISs can also organize, track, and determine howthe health enterprise is reimbursed for the work done in the lab, andhow the reimbursement information is exchanged.

As shown in FIG. 2, an enterprise server 42 can comprise the LIS 24 andthe HIS 38, or the ADT 26, LIS 24 and the HIS 38, as shown in FIG. 3.Alternatively, the HIS 38 and the ADT 26 operations can be combined in asingle server (FIG. 4), among other configurations. In the system 10 ofthe present invention, the LIS has a bi-directional interface with theserver 10 to allow collection lists to be sent from the LIS to theserver 20, and to allow collection data and canceled orders to be sentfrom the server 10 to the LIS.

LIS/HIS Data Interface

The LIS/HIS data interface 48 is an element for allowing for facilitatedcommunication for multiple modules sending and receiving data packetsand signals across a network. Examples include Health Level Seven (i.e.HL7 3.0), ASTM 1238, ASTM 1394, Dbase, Comma Delimited ASCII, and FixedLength ASCII.

Patient ID Printer

The patient ID printer 30 is a printer typically designated for printingpatient ID tags such as wristbands critical for accurate and efficientpatient identification and safety. Patient ID tag printers are usuallyconnected to a network and communicate with the ADT and HIS systems 26and 38. Devices can also be provided to produce RFIDs along with thebarcodes.

Specimen Management Server

The specimen management server (SMS) is a server 20 comprising adatabase and other programs and modules 60 (FIG. 6) for running andintegrating LIS 24, HIS 38, and client handheld systems 22 (e.g., a webserver, a SQL server, a LIS to SQL parsing application, and so on).Typically, the specimen management server 20 creates and updates itsdatabase with information specific to patients and specimen samplescollected from those patients. The specimen management server 20 in someembodiments is capable of executing a replication/synchronizationservice to maintain intermittent communication with the client 22. Insome embodiments of the present invention, functionality of the specimenmanagement server 20 can be integral to the LIS 24, HIS 38, or both. Inother embodiments of the present invention, the SMS 20 can be separatefrom the LIS 24 and HIS 38, but run on the same network as the LIS 24 inorder to receive updated information related to sample orders andaccession numbers generated through the LIS 24.

Unable to Complete Collection (UTC) Function

The Unable to Complete Collection (UTC) function is illustrated in FIG.7 as a “UTC” icon 46 on the display 23 of a handheld 22, and represents“Unable to Complete Collection.” This disposition status is used whenthere are multiple containers of the same type and one or more could notbe collected. When two or more of the same container type exist on anaccession number and one of the containers is not collected, theuncollected container is dispositioned as UTC. A system parameter can beset to control if a label prints for the uncollected container. Thislabel provides information to the laboratory as to the collection statusof the order. The uncollected container(s) cannot be “cancelled” becausethe laboratory needs to assess whether or not the test(s) can beperformed on the specimen that is collected. To disposition a test asUTC, the user selects the container and taps the UTC button on thehandheld display. A label prints if the system parameter for printingthis label is activated.

The Unable to Collect Collection (UTC) feature of the present inventionwill now be described. To better illustrate the advantages of a system10 and/or handhelds 22 that employ the UTC feature over existing medicalerror monitoring systems and devices, a description of how theseexisting medical error monitoring systems and devices process incompletecollection scenarios will first be provided.

The LIS/HIS assigns accession numbers to orders made by qualifiedmedical personnel for sample collections. The method of assigningaccession numbers and test data vary among LIS providers. When a doctoror other qualified medical personnel calls for specific tests for apatient, typically each test required demands at least part of a singlecollection container for the patient sample. However, some tests requiremultiple containers for the same test order to accommodate the analysismethodology or simply to provide enough sample volume. In a firstexample, it is possible that two dissimilar containers are required tocollect and contain the sample for the same test order. In a secondexample, a single test order might call for two identical containers tomaintain the collected sample for volume purposes. LISs also do somegrouping such that tests that require the same collection container willbe combined such that, for example, 4 tests that each require a RED10container would use “volume required” data to determine if the 4 testscan be run from a single container or if multiple containers arerequired.

Depending on the LIS manufacturer used by the healthcare facility, eachtest might be assigned an individual accession number or, in othercases, one accession number might be assigned to the set of testsrequired of a patient. This poses a problem for existing errormanagement devices with regard to communication to the LIS since only asingle message may be relayed to the LIS concerning the status of asingle test order (i.e., the order must be completed, not completed, orcancelled). With some existing LIS manufactures, there is no way to saythat a test order was not completed. When a nurse or phlebotomistmessages back to the LIS, he or she needs to have some status associatedwith each test order; otherwise, the LIS assumes the order was collectedor canceled, depending on the message format.

For a typical test, only one collection container is used. Givensuccessful conditions, the user should be able to collect the sample andhave it recorded by the error management system and proceed to the nexttest or patient. The successful collection is then reported to the LIS(e.g., the PDT is synchronized with the LIS through the HL7 interface).If for some reason the test is no longer necessary, as determined byqualified medical personnel, the user has the ability to cancel the teston the PDT which, in turn, informs the LIS of the cancellation. If anevent occurs which prevents the user from completing a required singletube collection order at the present time, the user may choose to deferthe test to a later time. In this case, the PDT maintains the testinformation in its memory and allows the user to return to the test at alater time. If a user skips an entire accession number, thus leaving itaround for a later collection, no message is sent to the LIS. No actionbeing performed is a non-event to the LIS. Existing LISs are configuredto only be informed when a test is collected or canceled.

In a test that requires two or more collection containers, given anexception event after collection of the first sample, an existing PDTcannot communicate to the LIS that one or more containers have beencollected and that one or more have not. This is because current LISsystems force a collection standard defined by messaging a single resultof the exam for a single accession number. Therefore, an existing PDTcannot communicate two results for a test within the same accessionnumber requiring multiple samples. The present system and provide asolution to this limitation of the LIS.

An embodiment of the present invention provides a means of generating amessage that can be sent to the laboratory staff indicating that one ormore collection containers were not successfully collected. Thispresents the user with the options of collecting the order, cancelingthe order, deferring the order, or designating an order as unable to becollected given the test circumstances within the same accession number.The error management device (e.g., the handheld 22) is able to evaluatethe status of the blood collection order and provide the proper optionsfor the user to choose from. The method of providing such options can bemade in the display 23 (FIG. 5) of the portable computing device 22(e.g., the UTC touchscreen button 46 in FIG. 7), or by means of amechanical button or toggle switch on the handheld 22, among otheroptions.

Referring to FIGS. 6 through 14, different screen displays are shown inaccordance with an embodiment of a portable medical device or handheld22. The handheld 22 can be used by nurses or doctors for management ofspecimen collection samples. The term “user” is used herein to describea person who uses a handheld to track samples of specimens collectedfrom patients, especially in the healthcare setting.

The handheld 22 is able to receive input data via a information codereader; such as a barcode reader. Input data can include, but is notlimited to, codes or other indicia existent on sample collectioncontainers, patient ID tags, and health practitioner personnel tags. Forexample, the system 10 and handheld 22 are configured such that a usercan remove the handheld 22 from its cradle 34 and then scan his or herID badge to communicate to the handheld 22 who is currently using thedevice and who will be performing the collection of specimen sampleswithin a given hospital ward, section, or floor. The scanner can beintegrated in the handheld. Alternatively, a handheld 22 can be securedto a sled accessory that contains a barcode scanner. The sled accessorycan have latching mechanisms to allow a user to removably the securesled accessory to the handheld 22. When the two components are securedtogether, a communications port on the sled accessory engages with asimilar port on the back of handheld 22 to transfer data and informationbetween the two components.

The handheld further comprises a display 23 such as a liquid crystaldisplay for displaying information of the devices for the user to see.Additionally, the display 23 can be of the sort that is used withfingers or a touch pen pressing on the display for executing relatedcommands.

The handheld 22 also includes internal memory for recording the resultsof a collection and the date and time of collection, as well as theorders assigned to the handheld 22. In one embodiment, handheld 22 has acommunications link for downloading or synchronizing the completed teststhat were ordered and stored in handheld 22. As described in furtherdetail below, the tests can also be dispositioned as canceled or part ofa UTC operation. The communications link may be a wireless link or ahard wire connection. The information may be downloaded or synchronizedto a computer associated with the ward or floor in a hospital, or alaboratory information system overall.

A screen (not shown) on the display 23 can provide a list of patientsassigned by the system administrator to the handheld 23 for collections.A web interface to the server 20 is described below in connection withFIGS. 16 through 29 which facilitates system administrator operations.The user then selects a patient from the list to view a new screen thatlists the tests ordered for that patient, as shown in FIG. 6. In theillustrated example, an order was made to perform a number ofcollections for a fictitious patient “Peter Peterson”. The screen inFIG. 6 prompts the user to scan the containers for a particularaccession number. The user does so by placing the collection tube in thenear vicinity of the scanner, as shown in FIG. 5.

FIG. 6 illustrates a handheld screen for a test wherein an accessionnumber has two of the same type of containers (i.e., RED) associatedwith it. With reference to FIGS. 7, 8 and 9, in the event that amultiple container test cannot be completed (i.e., not all of the REDcontainers are successfully collected), the handheld 22 can display amessage (FIG. 8) that the containers in the order will be dispositionedas UTC since the user was not able to collect a specimen. Further, thehandheld 22 can generate a command to print a label (FIG. 9) that can beattached to or inserted in a bag that is sent to the lab. Upon receivingthe bag, the laboratory technician would be able to read the sample andidentify that there was a sample collection deviation. The laboratorypersonnel could then further order an additional test (and thecollection containers associated with the test), or use the samples thatreached the laboratory and possibly allocate a portion of the specimenfrom those containers to perform the necessary test. Furthermore, themessage could be sent directly to the laboratory for the laboratorypersonnel to make the appropriate test decisions in preparation for thecollection specimens that were originally supposed to arrive at the lab.Notification could be sent via a wireless communications circuitrywithin handheld 22 or optionally through synchronization with the serverwhile in a cradle.

The UTC process is further illustrated in the flow chart depicted inFIG. 15. A physician writes an order or test in a patient's chart andthe test is entered into the hospital computer system (e.g., LIS) (block60). The test can then be provided from the LIS 24 to the server 20. Theuser of the PDT 22 to which the test is assigned (e.g., via a systemadministrator having a web interface to the server 20) uploads the PDTwith information (e.g., from the LIS), as indicated in block 62. Theuser connects the PDT or handheld 22 to a portable printer and bringsthese devices and specimen collection supplies to the collection site(e.g., patient's bedside). As indicated in block 64, the user thencorrectly identifies the patient (e.g., by reading patientidentification indicia), performs a collection, and scans the containerto create a label to correspond the container to the collection event.If the container does not have a barcode, the user can select the “M”touchscreen button 47 (FIG. 7) on the handheld 22 to generate a manuallabel. The user then prints a specimen label for the collectioncontainer containing the collected specimen.

With continued reference to FIG. 15, if the order does not require morethan one of the same type of container (block 66) and all of therequired specimens are collected, the user sends the specimen(s) to thelab for processing and designates the test as complete using thehandheld for reporting to the LIS (block 68). If the collection wasunsuccessful, the order can be canceled. If a deviation event occurredand the collection was unsuccessful (block 70), and the order requiresmore than one of the same type of container, the user selects the UTCbutton 46 to properly disposition the uncollected specimen as UTC (block72). The handheld then generates a warning message (block 74) that theother similar specimen containers will be given a UTC label (block 76)and/or a label for the collection bag or a communication signal will besent to notify laboratory personnel that not all of the requiredcontainers are provided. The user then proceeds to collect the remainingsamples needed to fulfill the order (block 78). In any event, the orderis not incorrectly designated as complete or canceled.

A method to acknowledge and record an unexpected event or exception casein data collection is necessary for any error management system. Itallows an accurate recording of an expected event that failed to occur,under certain circumstances, and assists with the determination ofwhether the unsatisfactory data collection event needs to besuccessfully repeated. In the hospital environment, when a patient bloodcollection order has been introduced to the LIS by a clinician, theorder might have been assigned with identical samples to be collectedfor additional testing volume of patient sample. However, if theadditional identical sample could not be collected based on thesituation, i.e., vein collapse, patient refusal to provide draw ofblood, or other emergency, the system 10 provides the UTC feature toalert the LIS personnel of the error. This feature provides LIS staffproper communication and tracking of the erroneous order collection andallows them to decide if the sample is sufficiently important to requirea future patient draw. Without the proper communication provided by theUTC feature of the present invention, LIS personnel might be required toreorder entire the specimen collection based on uncertainty of theinformation provided, causing analysis delays which leads to treatmentdelays.

The unexpected event error or exception case management communicationfeature is designed to provide information to laboratory personnel aboutthe unavailability of an expected sample. As stated above, thisinformation can be presented by a number of possible methods. Oneembodiment of the present invention employs means of outputting a printcommand to a printer upon selection of the UTC feature, that is,application of the UTC disposition to a particular repeated order via abutton on the handheld. The printer can print a message label, or evenbarcode with information notifying the unexpected event (e.g., failureto collect). This information label can be part of or appended to anexisting label, or can be completely separate from other collectionorder labels. This printed information can be sent to the laboratorywith the successfully collected samples to be handled by proper agents.In addition, the UTC scenario can be communicated back to the LIS via acollection message, as well as the printed label, such as a wirelesssignal updating the LIS database and directly being sent to laboratorypersonnel.

Other handheld screens include an icon (FIG. 10) to designate that anorder has special instructions and a corresponding dialog box (FIG. 11).In addition, a workload screen (FIG. 12) and cancellation reason screens(FIGS. 13 and 14) are also provided. The workload screen (FIG. 12)allows for recording of the types of collections, including a line drawmethod, as well as the number of attempts to perform the collection toaide in managing workflow among medical staff. If the handheld user wasunable to perform a collection, the workload screen (FIG. 12) allowsdesignation of a third party draw if needed. The workload screen can begenerated, for example, after a collection occurs and containers arescanned and labeled. The screen allows a handheld user to designate thetype of collection (e.g., via venipuncture or VP, a line draw such asvia a catheter, a finger stick or FS for filling a microcollection tube,a heel stick or HS, an arterial blood gas or ABG syringe, an open streamcollection such as for urine or other), as well as collection via aperson other than the person entering the collection data. Otherhandheld screens (not shown) can include, but are not limited to,patient lists sorted in accordance with selected criteria (e.g.,priority of the collection such as a STAT, timed or regular draw, or bypatient location such as by ward and/or room), order or draw proceduralreminders or special handling instructions (e.g., a specific andpredetermined order of draw) and order cancellation reason codes.

The system 10 is advantageous because it uses scanning of handheld user,patient and container IDs and correlates this information with specimencollections. In accordance with another aspect of the present invention,identifying labels can be printed from the system 10 to facilitatehospital business processes when those processes require a bar-codedlabel. The barcode label can be used for the facilitation of collectionof specimens in the system 10 or for purposes unrelated to the system 10and specimen collection. Typically, a patient has on him or herself awristband identifier with unique indicia identifying who they are. Thisis typically presented in a barcoded format, but can also be presentedthrough a RFID tag or by a displayed printed name. Also, typicallyportable handhelds and scanners are located in health facilities andinclude databases of patients that geographically align and relate tothe portion of the health facility assigned to the handheld.Additionally handhelds remote to an LIS only are concerned withinformation about specimen collection orders that match those patientsassigned to that portion of the health facility relevant to thehandheld. Patient information not relevant to the handheld is ignored toavoid wasting memory storage on the handheld. Specimen collection usinghandhelds to facilitate tracking of specimens have included handheldsthat can scan a patient, where the patient has an order pending from theLIS and the patient is in the handheld's database of relevant patientstracked in the handheld. However, sometimes in a healthcare facility acondition may exist where not all of the above conditions are met. Thesesituations require different types of ID labels to be generated toassist with properly labeling collected specimens when, for example,there is no pending order or an order is repeated.

One such ID label is a Generic Temp ID label. An exemplary use for tempIds is when a user needs to collect a specimen for which there is nopending order at the time of collection in the LIS. When an order maynot be in the system and there is an immediate need to collect aspecimen and connect the patient's information to that sample, thepresent invention also provides for the generation of a Demographic TempID label that includes some patient information and that can be used inthis situation, as well as the Generic Temp ID label. The server 20 canget patient demographic information from a ADT feed or an LIS feed.

The Generic Temp ID label works as follows. A patient may be moved fromone location of a hospital to another on a temporary or permanent basis.When the patient is moved from one location where he or she wasappropriately assigned to a handheld to another location where he or sheis not assigned to a handheld, information sent to the assigned handheldwill not reach the users responsible for collecting his or her sampleson his or her current floor, ward, location, etc. In this case, should adoctor or medical practitioner need to draw a blood sample not orderedby an LIS, he or she can activate a Generic Temp ID procedure. Thisprocedure includes the following steps.

As outlined in FIG. 30, the user scans into the PDT (or handheld) 90,activates the temp ID procedure setup 91, scans the patient's identityinformation 92 such as a barcode on the patient's wristband, thehandheld does not identify the patient as matching the list of patient'sassigned to the handheld 93-95, and the handheld causes to be printed orgenerated a specimen container label at least including the patient'sidentity information 96. Additional information which may be includedwith the generated label may include time of collection, time or datestamp (such as but not limited to time/date of scan and time/date ofprocedure), or user ID.

The Demographic Temp ID label works as follows. A patient may be locatedin the appropriate area of a health facility where his or herinformation correlates with the patient lists on the handheld. However,sometimes a condition may exist where a specimen is required to becollected that has not been ordered through the LIS. In this case,should be a doctor or medical practitioner need to draw a blood samplenot ordered by an LIS, he or she can activate a Demographic Temp IDprocedure. This procedure includes the following steps.

As outlined in FIG. 30, the user scans into the PDT (or handheld) 90,activates the temp ID procedure setup 91, scans the patient's identityinformation 92 such as a barcode on the patient's wristband, thehandheld identifies the patient as matching the list of patient'sassigned to the handheld 93-95, and the handheld causes to be printed orgenerated a specimen container label at least including the patient'sdemographic information in addition to or in place of the patient'sidentity information 97. Additional information which may be includedwith the generated label may include time of collection, time or datestamp (such as but not limited to time/date of scan and time/date ofprocedure), or user ID.

In both the Generic Temp ID label and the Demographic Temp ID label, thelabel preferably includes an adhesive backing for placement and at leasttemporary fixation on a container. Additionally, the label may include anotch for alignment with a collection container such as that describedin U.S. Pat. No. 6,428,640, herein incorporated by reference. Anotherexemplary use for a temp ID is when a nurse has difficulty collectingspecimens from a patient and wants to notify an additional user bygenerating a label to facilitate the collection process. For example,when a nurse encounters a patient from whom it is difficult to collect asample (e.g., due to a collapsed or difficult to find vein) and thenurse wants a more experienced phlebotomist to collect the sample, thenurse can print out a temp ID label. In response to these needs, thesystem 10 allows printing of the afore-mentioned two additional types ofIDs. If the system 10 does not have record of the patient from eitherthe ADT or LIS, then the Generic Temp ID can be printed. The content ofthe Generic Temp ID can be anything that the user (e.g., nurse) scanned,as well as the logged-in system user and system time. Typical usagewould be to scan the wristband of a patient so that the label printerwould print the wristband identifier in a bar-coded format, the systemdate, and the logged in system user.

When the system 10 does recognize the patient scanned because thepatient's data is in the system 10 database due to a previous messagefrom the ADT or LIS, then a Demographic Temp ID label is available to beprinted with specific demographic information. In addition to collectionpurposes, both of these Temp ID labels can be used for pharmaceuticalpurposes, among other uses. Further, a two-dimensional barcode (e.g., acode with bars in a horizontal and vertical orientation) on a wristbandcan be used to obviate the need for the system 10 to have knowledge of apatient in order to print a Demographic. Temp ID. The two-dimensionalcode allows for scanning of only a portion of the coded pattern forrecognition purposes. Thus, the two-dimensional code is useful whenpatient wristbands or barcodes on labels are only partially visible dueto wear or other damage. The following steps explain how to use the PDT22 to generate a label for a sample that has not been ordered in theLIS. A temporary ID label is placed on the patient sample until theorder has been entered into the LIS.

-   -   1. Log into the PDT.    -   2. Select the location.    -   3. From the Patient List Screen, tap the Temp ID button.    -   4. A Temporary ID Label screen appears.    -   5. Scan the barcode on the patient's wristband.    -   6. The PDT prints out a temporary patient ID label.    -   7. Place the temporary ID label on the tube after collection of        the sample.    -   8. Use the reprint function (tap the Printer icon) on the PDT if        additional labels are needed.    -   9. Log out of the PDT and cradle it to receive new orders.    -   10. After the patient's order has been received by the BD.id        System and downloaded to the PDT, log into the PDT.    -   11. Select the location.    -   12. At the Patient List Screen, scan the temporary ID label        instead of scanning the patient's wristband.    -   13. The order list appears.    -   14. Tap on the order that corresponds to the tube with the        temporary label (i.e. Scan the red top tube temporary label for        the test that requires a red top tube).    -   15. Tap the Manual collect button (M) to generate a specimen        label for that tube.    -   16. Place the specimen label over the temporary ID label.    -   17. Repeat the process if additional specimen labels are needed.    -   18. Complete the workload screen.    -   19. Log out of the PDT and re-cradle.        There are different types of tests (e.g., collections) that        require different label sets, and clinical practices associated        with collecting a specimen(s) and utilizing the label sets        appropriately. In accordance with another embodiment of the        present invention, the system 10 comprises an appropriately        constructed and populated database and attendant logic rules for        selecting and generating the appropriate label sets based on the        test code received by the system, i.e., a patient identification        system (PIS). The system 10 can also create and display        appropriate workflow messages and alerts that are displayed        proximally in time and location to the collection (e.g., via        screens on a handheld 22) that guide the user to utilize the        label sets appropriately and to take required or recommended        actions in collection and preanalytical processing of the        sample, e.g., tube handling, label application, conditions of        transport, recording vital signs of patients, and signing        documents. These messages can occur before, during, and after        the collection process and can be configurable based on user        input. The collection sets and messages can be based and        generated on test/order codes or clinical information system        codes (e.g., blood bank, laboratory, or microbiology). Examples        include, but are not limited to pop-up alerts (e.g., “Alert        doctor after collection” or “Specimen must be stored with ice”)        on handhelds 22 and unique subsets or combinations of labels        (e.g., extra process direction labels for collection containers        or bags to facilitate authorizations and workflow monitoring).        This aspect of the present invention therefore represents an        advantage over existing systems in which constant supervision is        needed to ensure that messages are acknowledged and practices        associated with the specific collection are performed. Unlike        the present invention, label sets in existing systems are not        generated at the collection location and time of collection must        be brought to the collection site and are therefore        disadvantageous.

The system 10 preferably comprises a web interface to the server 20 tofacilitate system administration functions. FIGS. 16 through 26illustrate exemplary screens generated by the web interface which can bedisplayed on an administrator workstation or other computing deviceconnected to the system 10 (e.g., via the server 20) and having accessto the web interface. Among other web pages, the web interface providesa pending specimen collection page (e.g., to view locations assigned toa workstation or handheld) and view data pages (e.g., to view canceledorders, removed orders, and orders by patient or transaction). The webinterface provides security options for controlling the display ofpatient names and tests (e.g., based on user's security access level),for defining headers and priorities, as well as providing options orreason codes for canceling orders, among other functions. The webinterface of the present invention provides administrative functionssuch as security functions (e.g., management of users such as by forcingpassword change and defining access rights for difference securityroles), and selection of system parameters (e.g., parameters are groupedby PDT, pending specimen page, system and web interface parameters).Further, the web interface provides for variance tracking (e.g.,variance groups and association of a variance with the actual collectionevent) and NCCLS order of draw for containers, both of which aredescribed in more detail below.

The Pending Specimen Collections page (FIG. 16) shows the orders for thepatients in the selected location(s). The orders are grouped by prioritywithin priority group and sorted by location, then bed, then scheduleddate/time, then container. This page can open as the default page forthe BD.id System web site.

Security

A system parameter allows the site to control if a user must log inprior to displaying this page. To safeguard patient confidentiality,there are two system parameters that control the number of characters tobe displayed for patient names and test orders. This partial display ofpatient data prevents the “casual observer” from acquiring patient orderinformation. When the system automatically refreshes the list, thesystem displays a “partial” format for the patient names and test namesbased on user settings. When a user clicks on the REFRESH NOW link, thesystem displays the entire patient name and test orders.

Locations

The Locations button allows the user to select locations to bedisplayed. This window allows the user with the appropriate accessrights to set the default locations for the workstation. However, theuser may edit the locations to view orders from other locations withoutchanging the default locations.

If a user has access rights for “Specify Location(s) for workstation”the window for Locations has two options available:

Option Definition Store as When this box is checked, the selectedlocations are stored workstation as the default locations for theworkstation. default View only When this box is checked, only ordersthat qualify to be PDT sent to the PDT are displayed on the PendingSpecimen eligible Collections page. orders If this box is not checked,all orders for the selected locations are displayed. An additionalcolumn “E” shows a checkmark for those orders that are eligible to besent to the PDT.

To Change the Selected Location(s):

-   -   1. Click on the Locations button. The Select Locations pop-up        window is displayed.    -   2. Select the location from the Available Locations list by        clicking the location and then click the right arrow button to        add the location to the Selected Locations list.    -   3. After selecting the locations, click the OK button. This will        display the Pending Specimen Collections for the locations        selected.        -   Note: Click the Cancel button to start over. To remove a            location from the selected list, click on it and then click            on the left arrow button. To remove all items in the            selected list, click the Clear All button. Select the            Restore Defaults button to select the locations that were            used during the last web page session.

Canceling Orders

The first column header (Cancel) on the list contains a checkbox foreach order on a specific container. The orders for a container arecanceled by checking this box and pressing the Cancel button on thebottom of the page or pressing the ENTER key. The system requires theuser to login to ensure the user has access rights for this function.The Cancelled Orders page displays the selected orders. A cancel reasonmust be selected before the cancellation can be entered. The canceledorder data may be sent back to the LIS if the interface supports thisfeature.

Changing the Sort Order

The Pending Specimen Collections page allows you to sort in ascending ordescending order based on Patient, Wristband, Schedule, Location, andContainer for all priority groups.

-   -   To sort in an ascending order, select the Patient, Wristband,        Schedule, Location or Container header and click. An “A” on top        of a “Z” with a down arrow indicates an ascending sort method.    -   To sort in descending order, click the header with the “A” and        “Z”. A “Z” on top of an “A” with a down arrow indicates a        descending sort method.    -   To sort using the default parameters (by priority and room/bed        within location within collection date), click the Default Sort        Order button located in the upper right corner of the page.

Eligible (E) Column

The Pending Specimen Collections page displays an “E” column under eachpriority header when all orders have been defined to appear on thispage. The “E” column indicates orders that are Eligible for download tothe PDT. In most instances the orders are download to the PDTapproximately 180 minutes before the specimen collection is due.

Viewing the Pending Specimen Collection List

-   -   1. Open the BD shortcut on your desktop. The Pending Specimen        Collections page is displayed. The list may also be displayed by        selecting the Pending Specimen Collections option from the        Specimens menu.    -   2. Enter your Username and Password if required.    -   3. Click the Locations button. The Select Locations pop-up        window is displayed.    -   4. Select the location from the Available Locations list by        clicking the location and then click the right arrow button to        add the location to the Selected Locations list.        -   Note: To remove a location from the selected list, click on            it and then click on the left arrow button. To remove all            items in the selected list, click the Clear All button.            Click the Restore Defaults button to select the locations            that were used during the last web page session. Click the            Cancel button to start over.    -   5. When you have finished selecting the locations, click the OK        button. The system displays the Pending Specimen Collections for        the locations selected.    -   6. To view the full patient names and Test data on the Pending        Specimen Collection, click the Refresh Now link. A user login        may be required.        The Header definitions for the Pending Specimen Collections page        may be defined and edited by the user. With reference to FIG.        21, the definitions include the priority codes assigned to each        header, the sorting of the priority codes within a header and        the colors to be applied to each header. The Pending Specimen        Collection page groups pending orders by priority code. The user        associates each priority code to a user defined group header,        e.g., STAT, Timed, Routine, etc. If a priority code is used for        Timed Test(s), refer to the system parameter for defining the        Warning Time Window that alerts the user that a Timed Test is        scheduled and has not been collected.

Managing Priority Groups

The Priority Groups are defined with their headers and colors.

Field Description Priority Group Name Enter the name for this group oforders. Priority Header Label Enter the text for the priority headerthat prints as a second line under the group name. This text will onlyappear if the box to Display Priorities is selected. Display PrioritiesCheck this box if the priority codes assigned to this header are todisplay with the Priority Header Label. Sort Order Enter a value from0-255 to determine the sorting of this header in relation to the othergroup headers. Display Special Check this box if Special InstructionsInstructions are to be displayed for this group. Group Header ColorsSelect the background color and the text color for the header. GroupTable Colors Select the background color and the text color for thetable.

Managing Priorities

The Priority Codes are entered and associated with a Priority Group.

Field Description Priority Enter a priority code. LIS Priority Enter theLIS priority code. PDT Short Priority Enter the abbreviated form of thecode to be displayed on the PDT. For example, “S” for STAT. Sort Orderwithin Group Enter a value from 0-255 to determine the sorting of thispriority within the group. Timed Test Check this box if this priority isused for a Timed Test. Priority Group Select the Priority Group todisplay orders having this priority code.

Priority Groups are Defined Before Priority Codes. To Enter a NewPriority Group:

-   -   1. From the Specimen menu, select the sub-option Manage Priority        Groups under Priorities.    -   2. Enter your Username and Password.    -   3. The View Existing Priority Groups page is displayed if you        have access rights.    -   4. Select the Add New button. The Add New Priority Group page is        displayed.    -   5. Enter the information in the fields.    -   6. To save, click Save. To ignore any changes, click the Cancel        button.

To Edit a Priority Group:

-   -   1. From the Specimen menu, select the sub-option Manage Priority        Group under Priorities.    -   2. Enter your Username and Password.    -   3. The View Existing Priority Groups page is displayed if you        have access rights.    -   4. Click on the Edit icon. The Edit Existing Priority Group page        is displayed.    -   5. Modify the fields.    -   6. Click the check box next to Display Priorities to display the        priority codes assigned to this Priority Group with the priority        header label.    -   7. To save changes, click Save. To ignore, click Cancel.

To Enter a New Priority Code:

-   -   1. From the Specimen menu, select the sub-option Manage        Priorities under Priorities.    -   2. Enter your Username and Password.    -   3. The View Existing Priorities page is displayed if you have        access rights.    -   4. Select the Add New button. The Add New Priorities page is        displayed.    -   5. Enter the information in the fields.    -   6. To save, click Save. To ignore any changes, click the Cancel        button.

To Edit a Priority Code:

-   -   1. From the Specimen menu, select the sub-option Manage        Priorities under Priorities.    -   2. Enter your Username and Password.    -   3. The View Existing Priorities page is displayed if you have        access rights.    -   4. Click on the Edit icon. The Edit Existing Priorities page is        displayed.    -   5. Modify the fields.    -   6. Click the check box next to Active to remove the check and        inactivate this Priority.    -   7. To save changes, click Save. To ignore, click Cancel.        The System Parameters allow the user to tailor the system to        their environment. Key features of the system can be activated        or disabled based on the internal procedures of each client        site. The parameters are grouped according to the system module        affected: PDT Parameters, Pending Specimen Collections Page,        System Parameters, and Web Parameters.

As stated above, another advantage of the system 10 is its ability toprovide variance tracking that is linked to an actual collection eventor instance in accordance with another embodiment of the presentinvention. An order starts in the LIS and is delivered to the server 20,for example, and is then delivered to the end user for collection. Uponcollection, the specimen and container are delivered to the laboratorywhere it is reviewed. If the collection or specimen is determined to bein error by the laboratory, the system is capable of storing andreporting the collection error. The error is then entered into thesystem 10 (e.g., via the server 20), which links the error to thespecific collection, which allows long term reporting of who, when andwhere errors in specimen collection have occurred. The information isreported back to the users via textual and/or graphical reports via theweb interface or remote computing device.

In an embodiment of the present invention, the user enters the varianceinformation into the system 10 using the web interface and lists thevariance that occurred and the person that reported the variance(s), andselects the collection that created the collection specimen that wasflawed. The user then can generate reports that include informationpertaining to the variances including the identify of the user, the PCTunit, the specimen collected, the time of the collection, and thecollection method used in generating the specimen. It is to beunderstood that the term “collection” refers to whatever list of samplesintended to be collected during the collection process. In other words,one or many blood collection tubes may signify one collection inconnection with variance tracking.

The management of variances via the web interface will now be described.A variance is defined for each type of error incurred during specimencollection. The variance group (FIG. 26) allows the user to assign eachvariance to a category in order to view statistics by groups rather thanviewing each individual variance. Examples of Variance Groups are:Analytical Errors (hemolysis, short draws, incorrect container),Specimen Identification Errors, Blood Bank Specimen Errors. The groupnames are defined first in order to assign the individual variances to agroup.

The variance form contains the following fields:

Field Definition Variance Code Enter a code for the variance. (e.g.,CLTD for Clotted). Variance Group Select the group associated with thecode. Active When editing a code this option appears. To inactivate acode, click on the box to remove the check.

Entering a Collection Variance

To enter a collection variance, a selection form is displayed to findthe patient's specimen associated with the variance. After finding thespecimen, click the Append Variance icon. The system displaystransaction data for the specimen and allows you to check theappropriate variance and enter the name of the person who reported thevariance.

Collection Variance Search

The Collection Variance search is used to find the patient specimen toenter variances that are manually recorded on the laboratory variancelog sheets. The data for the patient specimen is displayed and allows avariance to be associated with the specimen and enter the user whoreported the variance.

-   -   1. From the Admin menu, select the sub-option Collection        Variances under Manage Variances.    -   2. Enter your Username and Password.    -   3. The Collection Variance Enter Criteria page is displayed if        you have access rights.    -   4. Enter criteria in the selection form fields and click Search        to find the patients/specimens matching the criteria entered.        -   Note: None of the fields are required. Clicking Search with            no selection criteria will display a list of all            patients/specimens that qualify.    -   5. The Collections Matching Criteria page is displayed.    -   6. Click the Append Variance icon next to the patient        information you want to select. The Append Variance page is        displayed with the patient/specimen information.    -   7. Click the check box next to the variance to associate the        variance with this specimen.    -   8. Select a user from the User in the system drop down box or        type a user name in the User NOT in the system box for the user        who reported the variance.    -   9. Click Save to save the variance information or click Cancel        to ignore the information and return to the Collections Matching        Criteria page.

Edit Variance Definitions

A variance is defined for each type of error incurred during specimencollection. To add a new variance:

-   -   1. From the Admin menu, select the sub-option Edit Variance        Definitions under Manage Variances.    -   2. Enter your Username and Password.    -   3. The View Existing Variance Definitions page is displayed if        you have access rights.    -   4. Click Add New. The Add New Variance Definition page is        displayed.    -   5. Enter data in the Variance field.    -   6. Enter data in the Variance Code field.    -   7. Make a selection from the Variance Group drop down list.        -   Note: Variance Groups must be defined first before assigning            the individual variance to a group.    -   8. Click Save or Save & Add Another to save the variance        information. To ignore, click Cancel.

To Edit a Variance:

-   -   1. From the Admin menu, select the sub-option Edit Variance        Definitions under Manage Variances.    -   2. Enter your Username and Password.    -   3. The View Existing Variance Definitions page is displayed if        you have access rights.    -   4. Click the Edit Variance (pencil) icon next to the variance to        be edited. The Edit Existing Variance Definition page is        displayed.    -   5. Modify the fields for this variance.    -   6. Click the check box next to Active to remove the check and        inactivate this variance.    -   7. To save changes, click Save. To ignore, click Cancel.

Edit Variance Groups

Variance Groups allow assignment of individual variances to categoriesfor viewing statistics. For example, a variance group for AnalyticalErrors may include these individual variances: Hemolysis, Short Draws,Incorrect Container, Specimen Identification Errors, etc. VarianceGroups must be defined first before assigning individual variances to agroup.

To Add a New Variance Group:

-   -   1. From the Admin menu, select the sub-option Edit Variance        Groups under Manage Variances.    -   2. Enter your Username and Password.    -   3. The View Existing Variance Groups page is displayed if you        have access rights.    -   4. Click Add New. The Add New Variance Group page is displayed.    -   5. Enter data in the Variance Group field.    -   6. Enter data in the Short Name field.    -   7. Click Save or Save & Add Another to save the information. To        ignore, click Cancel.

To Edit a Variance Group:

-   -   1. From the Admin menu, select the sub-option Edit Variance        Groups under Manage Variances.    -   2. Enter your Username and Password.    -   3. The View Existing Variance Groups page is displayed if you        have access rights.    -   4. Click the Edit Variance Group (pencil) icon next to the        variance group to be edited. The Edit Existing Variance Group        page is displayed.    -   5. Modify the fields for this variance group.    -   6. To save changes, click Save. To ignore, click Cancel. Click        Delete to remove the variance group.        In accordance with another aspect of the present invention,        means are provided to allow the system 10 to assign collections        based on some criteria derived from information contained in the        Clinical Information System (CIS), provided externally, or as        defined within the system to a set of defined health care        providers, a specific individual, or to a specific device or set        of devices. In one example, this aspect of the system 10 can be        used to take information from the CIS and target an order to be        collected by a specific category of user, such as a nurse or a        phlebotomist. In another example, the system 10 can take        information from the CIS and target an order for a set of        devices (e.g., handhelds 22) specifically configured for STAT        orders. In another example, the system 10 can take information        from the CIS and associate an order to a specific user (scanning        of user would drive the set of orders displayed for that user).

The order of draw aspect of the present invention will now be describedin conjunction with FIGS. 27, 28 and 29. In the hospital and laboratoryenvironment, blood samples are frequently ordered by doctors to becollected and sent to the lab for blood analysis. The samples of bloodare typically collected into evacuated collection containers or tubesusing some sort of venipuncture procedure. Such procedures include, butare not limited to, using venipuncture devices such as wingsets,double-ended straight needles, catheter ports, etc. All of these devicesare used with a non-patient needle which allows for a blood collectiontube to establish fluid communication between the patient's vein and theevacuated chamber inside the tube.

Blood collection tubes come in many varieties and have differentadditives, fill volumes, and other characteristics resulting in a myriadof containers to be chosen from when a specific test is ordered. Forexample, some tubes accelerate clotting of blood while others postponeor prevent clotting of blood. Other tubes provide a density gradient sothat blood collection tubes can be centrifuged, causing their cellularcomponents to be separated by specific gravity.

Typically a nurse or phlebotomist will receive an order to collectcertain tubes based on the type of test that was ordered by thelaboratory and/or doctor. Depending on the hospital procedure thatcommunicates to the nurse or phlebotomist what tubes are needed, therecan exist a lack of information guiding the phlebotomist in which orderto collect the containers or tubes ordered. This information isimportant because certain tube additives may contaminate the specimen ina subsequent tube if the additive on the previous tube contaminates theblood collection needle used to deposit sample into the subsequent tube.In general, the order of draw is designed to prevent cross contaminationthat can result in erroneous lab results. A specimen is the biologicalrepresentation of a patient and therefore if the phlebotomist doesn'tuse the proper order of draw, the biological make up of that specimencould be compromised and no longer is a true representation of thepatient. Something as seemingly simple and undetectable as changing theorder of draw during the procedure can create a change in therepresentation of that specimen. Care and consideration of the properorder of draw is significant to good patient care, and therefore ademonstrated need for the present invention.

To avoid the contamination of additives between tubes, a guideline hasbeen set by a widely recognized standards organization to avoid thispotential problem. The guideline provides a recommended order in whichthe tubes should be collected. One generally recognized standardsorganizations is the National Committee for Clinical LaboratoryStandards (NCCLS). Hospitals and laboratories typically displaythroughout their institutions in pamphlets or posters the recommendedNCCLS suggested order, thereby assisting the nurse or phlebotomist indetermining what order to draw tubes when multiple tubes are to be drawnfor a certain test.

When a suggested list is not readily available, the nurse orphlebotomist relies on his or her experience or memory to chose theorder he or she thinks is correct. The flexibility a nurse orphlebotomist has to deviate from the preferred order of collectionallows for some collections to be collected in an erroneous manner,thereby subjecting certain tubes to the possibility of incorrectlaboratory results. In order to reduce and hopefully prevent thepossibility for erroneous collections, an embodiment of the presentinvention utilizes a handheld specimen order display to reduce oreliminate erroneous collections.

Such embodiment includes the use of an algorithm to communicate to ahandheld device the correct order of containers to be drawn. Theinvention can be implemented in an LIS, in a server that bridges the LISand the handheld, or to the handheld directly. In some embodiments, theLIS can directly communicate to at least one and usually a plurality ofremote handheld devices, those specimen containers that should becollected from a patient assigned a pending test. When referring todirect communication, the LIS can output a priority list of containersthat is displayed on the handheld by a sequencing feature in either ahandheld resident program or an algorithm in the LIS. When referring toindirect communication, the LIS can send to intermediate systeminformation that the intermediate system translates into the propersequence acceptable and displayable on the handheld. The intermediatesystem could be, for example, a server in communication with the LIS.Other intermediate systems are contemplated and possible to use, as longas the intermediate system has algorithms to translate the containersinto a preferred sequence that is displayed on the handheld so that anacceptable order of draw is communicated to the user.

Typically, the LIS has defined within it a database of mnemonics foreach collection container used to collect patient specimens. Forexample, the mnemonic RED6 might be equivalent to a serum (red top) tubethat has a 6 ml draw volume. Mnemonics are used to communicate to thenurse or phlebotomist which tube or container should be used to carryout a sample collection procedure. Nmeunomics are typically defined bythe laboratory or hospital and correlated to a specific tube orcontainer such as by a tube or container catalog number. In general,each container or tube has only one mnemonic as well as only oneassociated catalog number.

By constructing an appropriately populated database and logic rules fromorder codes and container mnemonics resident in a CIS (computerinformation system, more specifically a hospital information system, andeven more specifically a laboratory information system), physicalproducts needed for specimen collection are displayed in the appropriateorder of collection based on a recommended standard, e.g., NCCLS. Aremote computing device is preferably used to display the information toa care provider.

In one embodiment of the present invention, a server receives ordersfrom a CIS containing order codes and container mnemonics. Containermnemonics indirectly determine what physical products (tubes orcontainers) that can be used in the collection of the specimen. Theserver presents the order of those mnemonics to the user collecting thebiological fluid samples from a patient in a correct sequence such thatthe physical products are collected in accordance with NCCLS recommendedorder of collection.

Specifically, the present invention (a server 20 such as theafore-mentioned BD.id system) provides a means to map physical productsto container mnemonics thereby associating a NCCLS sort order with thecontainer mnemonic. A sort value is generated for all types ofcontainers identified in the NCCSL sort order. A high priority NCCLSsort value means that the container or tube associated with the mnemonicis presented to the phlebotomist or nurse in a manner to indicate such.In the case where no physical product is associated with a containermnemonic, the lowest priority NCCLS collection sort value is applied tothe mnemonic. On the remote computing device, the orders are thendisplayed using the NCCLS sorting value associated with each containermnemonic. Therefore, the user of the remote computing device will knowexactly which order should be used and in what sequence.

In one embodiment, the display on the handheld can display the orders inorder of priority (commercial embodiment). In another embodiment, thedisplay on the handheld can display the orders in a sequence that isdifferent than the order of priority, but could additionally display apriority identifier so that the user would know in which order to drawthe samples. For example, a priority ranking for each container could bedisplayed adjacent to the container so that even if the order ofcontainers displayed is not in an order that correlates with the prioryranking determined by the sort value generator, the user still knowswhich containers to collect first.

The desired order for collecting specimens is defined by a standardacceptable to the laboratory. The laboratory LIS may have within it aNCCLS standard, a standard derived by another third party, a standarddeveloped by the institution or hospital, or a combination thereof.Preferably, the NCCLS standard is used to determine proper tube draworder for collecting containers of a biological fluid specimen, such asblood. The NCCLS standard might be dependent on which type of collectionis performed, and therefore it is contemplated that the invention canacknowledge the difference if what type of collection is to be performedand make adjustments as needed. (Types of collection include evacuatedtube use for venipuncture; syringe draws, or capillary draws). The mostcommon type of collection performed in hospitals is through the use ofevacuated blood collection tubes. Other forms of collections include butare not limited to capillary draws, and syringe draws. The order fordrawing blood collection tubes might vary when compared to the order forcapillary or syringe draws. One aspect of the present invention is toprovide algorithms that differentiate which mnemonic is associated withthe type of draw, and then to select the appropriate NCCLS standardapplicable to that type of collection procedures.

Below is a representation of NCCLS standard H3-A3 which recommends thattubes be collected in the following order of draw:

-   -   1) blood culture tube or bottle (aerobic and anaerobic)    -   2) plain serum tubes (e.g., a red stopper-glass non-additive or        plastic clot activator)    -   3) * coagulation tubes (e.g., sodium citrate tube additive with        a blue stopper)    -   4) ** non-citrate additive tubes, herein referred to as additive        tubes (e.g., with a green, lavender, or gray stopper, or other        additive tube). Examples include sodium heparin, lithium        heparin, EDTA, Oxalate fluoride, etc. * When a black-topped        buffered sodium citrate tube has been requested, it should be        filled after the plain serum tubes but before the additive        tubes, therefore, before or after the coagulation tubes.        Black-topped buffered sodium citrate tubes are used for        sedimentation rates.** When multiple additive tubes are        requested, their sequence of draw within the along with the        coagulation tubes prior to the non-citrate additive tubes. When        several different non-citrate additive tubes are requested,        their order within the broader group is also important. For        example, the order for additive tubes are as follows:    -   1. Heparin-containing (green stopper) tube.    -   2. K₂ EDTA or K₃ EDTA containing (lavender stopper) tubes.    -   3. Clot activator (gray and yellow stopper) tube (CAT)        containing thrombin.    -   4. Gel or mechanical separator (gold stopper) tubes (i.e., serum        separator tube, or SST).        The order in which multiple tubes are collected can affect the        results of a test. The “order of draw” is a set of guidelines        prepared by the National Committee for Clinical Laboratory        Standards (NCCLS) to minimize problems associated with multiple        tube collections. With the exception of blood cultures or other        tests that require special techniques to minimize the        possibility of microbial contamination, the order in which the        evacuated tubes are used is different from the order in which        tubes are filled when using a syringe to draw the blood. This        order is designed to reduce interference in specimen testing        caused by inadvertently mixing additives between tubes. This can        occur when blood in a tube that contains an additive makes        contact with the needle that punctures the tube's rubber top.        Blood remaining within the needle may be transferred to the next        tube, contaminating that tube, thus affecting test results on        that specimen. Each laboratory may have their own Order Of Draw        Policy.

SAMPLE ORDER OF COLOR COMMENTS THAT MAY BE DISPLAYED ON THE HANDHELD INDRAW OF STOPPER ADDITION TO THE RECOMMENDED SEQUENCE. 1 Blood CultureWhen a culture is ordered along with any other Collection blood work,the blood cultures MUST be drawn Bottle first. 2 Plain Red Contains noadditive in glass tubes (clot activator Serum Tubes additive in plasticserum tubes). Do not mix or invert. Used for serum test(s), which cannotbe collected in SST tubes. 3 Light Blue Referred to as Blue Top tube.Contains Sodium Citrate anticoagulant. This tube is used mainly incoagulation studies. 4 (SST) Throughout this Guide, we refer to this asSST. Red/Gray or Most commonly used tube where serum is Gold Plasticrequired. Contains a gel separator and clot Cap activator. 5 Royal BlueContains Sodium Heparin anticoagulant This tube (Green Band is requiredfor collection of trace elements. on Label) 6 Dark Green Contains SodiumHeparin anticoagulant. 7 (PST) Contains Lithium Heparin anticoagulant aswell as Light Green a gel separator (mint) Green/grey 8 LavenderContains EDTA anticoagulant. 9 Pale Yellow Contains Acid CitrateDextrose Solution ‘A’ and is (ACDA) used primarily for Flow Cytometrytesting. 10 Pale Yellow Contains Acid Citrate Dextrose Solution ‘B’ andis (ACDB) used primarily for Bone Marrow Donor Registry 11 Gray Notstocked by CLS Community Collection Sites, but is stocked in Acute Carelocations. Contains Sodium Fluoride and Potassium Oxalate anticoagulantFIGS. 27, 28 and 29 more clearly show the systems described above basedon the present invention. As shown, each system provides guidelinesregarding the “order of draw” that are accessed and used to provide thehandheld with a proper list of containers in a sequence that is requiredfor collection. Each FIGS. 27, 28 and 29 shows a different architecturefor the system. For example, FIG. 27 shows a system wherein LIS 100receives guidelines for collection order 120 in a database 105 ofcontainer and associated container priorities and then uses thatdatabase 105 to create 104 a new list of containers from a list that wastranslated from an accession number into a list. As shown in FIG. 27,the system includes the following steps. First, a test is ordered for aspecific patient 101, an accession number is created in the LIS 102, andthen the LIS translates the accession number into a list of containersto be collected in a sequence not aligned with the guidelines 103. TheLIS incorporates 104 that list into a new list using the database 105 ofcontainer and associated container priorities per a guideline to createa new list of containers in alignment with the guideline. The LIS thentransmits 106 to the handheld the proper order for containers to becollected. In the last step 107, the handheld 110 receives the list ofcontainers in the sequence determined by the guideline and displays thesequence on the handheld when accessed by a user. The system shown inFIG. 28 is very similar to the system shown in FIG. 27. However, thestep of incorporating information from the database into a new list 204is now performed by handheld 210 and the database 205 of container andassociated container priorities per a guideline is stored in handheld210, such that handheld 210 directly accesses guidelines 220 anddisplays 204 the list of tubes in the appropriate sequence. Finally,FIG. 29 shows a system in which a server 330 resides between LIS 300 andhandheld 310 and the features of incorporating 304 and storing thedatabase 305 are both provided by server 330.

In one embodiment applicable to blood collection tubes, a test might besent from the LIS to the handheld, where the test does not call for aserum tube (red top), but does call for a coagulation tube (light bluetop). Although this situation does not specifically call for a serumtube, a further embodiment of the present invention may indicate to theuser to use a discard tube. Without using a discard tube, there is apossibility that tissue thromboplastin can contaminate the coagulationtube specimen during the venipuncture. To avoid this, the phlebotomistor nurse is usually told to use a serum tube (red top) and discard thetube in an appropriate disposal container commonly found in hospitalsfor medical waste prior to drawing the coagulation tube. To encouragethe following of this procedure, the invention offers an embodimentwherein the server communicates to the handheld information for the userto use during collection. For example, if a test is ordered where thetest does not call for a serum tube (red top), but does call for acoagulation tube this occurs, the server or the LIS might perform one ofthe following events:

-   1. Present indicia on the handheld that communicates to the user    that a “discard tube” or plain serum tube should be drawn prior to    the coagulation tube.-   2. Add a discard tube to the list of tubes to be drawn. In one    embodiment, this would be displayed as a red-top tube. In another    embodiment, this would be displayed as a “discard tube” or    equivalent thereof.    A further embodiment includes a provision for after collection and    upon scanning the tubes, a tube with indicia such as a barcode that    is read by the handheld scanner element should deliver a message to    the user that the tube is to be discarded and not sent to the lab.    This could be accomplished by the scanner producing an audible alert    to the user, a message display on the handheld, or by not printing a    new tube label upon scanning of the tube wherein scanning of tubes    on the patient's list to be drawn would print from a printer in    digital or analog communication with the handheld, directly or    indirectly.

In another embodiment of the present invention, the LIS might sendmnemonics that correlate to microcollection tubes used for capillaryblood collection. Microcollection tubes do not have a vacuum to drawblood into the container, for they rely on capillary action and gravityto fill the specimen container. Also, capillary blood collectiontechnique is traditionally performed by lancing through the capillarybed of a patient's finger or heel, rather than accessing the patient'veins. Lancing the patient's skin allows for blood to bead into drops onthe patient's skin surface, and thus allows for the microcollectioncontainer to filled by a scooping method performed by the nurse or bythe use of gravity wherein the tube catches drops of blood falling fromthe patient's skin. Should the LIS sent to the handheld (directly orindirectly through a server) mnemonics that correlate to microcollectioncontainers, the order of draw that gets shown on the handheld screen forone patient might deviate from that used for evacuated blood collectionsystems. Therefore, a system would recognize that the mnemonics relateto capillary blood collection, and thus may use a different set ofcollection priority to establish the sequence presented to the user.

In one embodiment, the handheld displays capillary collection containersin the following order:

1. EDTA

2. Additive tubes for whole blood3. Serum tubesAs stated above, the system may provide a default NCCLS sort order foreach product. The NCCLS sort order requires a container to be mapped toproducts that have a NCCLS priority. If one container is mapped to atleast two products and those products have different NCCLS priorities,then the container shall be listed using the lower NCCLS priority (thehigher number).

EXAMPLE

The container mappings look like:

NCCLS Product Priority Container Product 2 4 LAV5 Product 3 3 BLUEProduct 4 4 GREEN 2 RED Product 5 2 REDPatient 1 contains 5 orders with the same accession number:

Priority Time Container Tests S 06:00 GREEN LYTES S 06:00 LAV5 CBC S06:00 GREEN REFX S 06:00 RED METB S 06:00 BLUE PT, PTTFor Patient 1, the orders would be displayed on the Order List Screenas:

Priority Time Container Tests S 06:00 RED METB S 06:00 BLUE PT PTT S06:00 LAV5 CBC S 06:00 GREEN REFX S 06:00 GREEN LYTESIn all embodiments of the invention, the order of tubes drawn must beexecuted by accessing a database. In all embodiments of the invention,the types of tubes must be determinate. Therefore, either the system canreceive a test and then construct which tubes are connected to that testand finally sequence the tubes displayed on the handheld. Otherwise, thesystem can receive a list of tubes that an LIS system already identifiedas being required, wherein the system merely corrects or ensures thatthe sequence of tubes to be drawn are accurate to a standard.

Embodiments of the present invention have been described, and it shouldbe understood that the invention is not limited to the details thereof.Various modifications and substitutions have been suggested in theforegoing description, and others will occur to those of ordinary skillin the art. All such substitutions are intended to be embraced withinthe scope of the invention as defined in the appended claims.

1. A handheld system comprising: a processor configured to receiveinformation relating to collection of at least one patient derivedspecimen; an interface configured to display at least a portion of theinformation; and an output device configured to output a message, basedat least in part on the at least a portion of the information,indicating that at least a portion of said collection has not beencompleted.
 2. A handheld system comprising: a processor configured toreceive information relating to collection of at least one patientderived specimen; an interface configured to display at least a portionof the information; and an output device configured to output specialinstructions associated with the collection based on at least in part aportion of the information.
 3. The system of claim 2, wherein thespecial instructions relate to at least one test to be performed on theat least one specimen.
 4. The system of claim 2, wherein the specialinstructions relate to at least one container used for the collection.5. A handheld system comprising: a processor configured to receiveinformation relating to collection of at least one patient derivedspecimen; an interface configured to display at least a portion of theinformation; and an input device for entering workload informationregarding at least a portion of the collection that has been filled orattempted to be filled based on at least in part a portion of theinformation.
 6. A handheld system comprising: a processor configured toreceive information relating to collection of at least one patientderived specimen; an interface configured to display at least a portionof the information; and an input device configured to input dataregarding cancellation of at least a portion of the collection that isattempted based on at least in part a portion of the information.
 7. Ahandheld device user interface for collecting specimen samples,comprising: an interface configured to receive at least one guidelinerelating to an order in which specimen samples should be collected; andan output screen for displaying a sequential list showing the order inwhich the specimen samples should be collected based on the at least oneguideline.
 8. A system for collecting specimen samples, comprising: aninterface configured to receive information regarding priorityassociated with specimen sample containers to be filled; and a handhelddevice output screen segregated into a number of screen areas, at leastone of the screen areas relating to showing specimen sample containersto be filled, wherein said at least one screen area relating to showingspecimen sample containers to be filled includes information regardingpriority associated with the specimen sample containers to be filled. 9.A method for specimen collection, comprising: receiving an order of aselection of specimen collection containers to be collected; accessing adatabase that associates priority to each of said specimen collectioncontainers; sorting the specimen collection containers based on saidpriority; and displaying said priority on a screen of a handheld device.10. The method of claim 9, wherein said sorting of said specimencollection containers is performed by an algorithm resident in an LIS.11. The method of claim 9, wherein said sorting of said specimencollection containers is performed by an algorithm resident in thehandheld device.
 12. The method of claim 9, wherein said sorting of saidspecimen collection containers is performed by an algorithm resident ina server capable of electronic communication with said handheld device.13. A user interface for collecting specimen samples, comprising: aninterface configured to receive information regarding a variance toinstructions associated with a filled specimen sample container; and anoutput screen segregated into a number of screen areas, at least one ofthe screen areas related to a window showing specimen sample containersthat have been filled, wherein said at least one screen areas showingspecimen sample containers that have been filled includes theinformation regarding the variance.
 14. A system for collecting specimensamples, comprising: an output configured to display sample collectionand management information to the user; and a processor configured toindicate that a portion of the specimen samples have been collected. 15.A handheld communication device comprising: a display unit coupled to aprocessor having access to a computer-readable storage 10 medium havingstored therein computer-readable instructions, which, when executed bythe processor, cause the processor to display a user interface on thedisplay of the handheld communication device, said user interfacecomprising: a main screen communicating at least one test collectionspecimen container to be collected from a patient; and an icon displayedat least temporarily on said screen, whereby activating the icon informsthe handheld communication device to print a label indicating that saidtest collection specimen container was not collected.
 16. A method forcollection of sample specimens, comprising: reading at least oneidentification code associated with at least one of the following: atleast one container and at least one patient identification tag;receiving a set of rules associated with the at least one identificationcode; determining whether the set of rules associated with the at leastone identification code is followed; and outputting a message thatindicates when the set of rules has not been followed.
 17. The method ofclaim 16, wherein said identification code is a barcode.
 18. The methodof claim 16, further comprising: displaying instructions on saidportable handheld device if said set of rules has not been followed. 19.The method of claim 16, further comprising communicating a notificationto a remote location if said set of rules has not been followed.
 20. Amethod of generating an incomplete specimen collection order,comprising: sending to a handheld device an order including a specimencollection protocol; displaying said order; determining whether thespecimen collection protocol was performed in accordance with saidorder; and communicating an incomplete collection message when thespecimen collection protocol was not performed in accordance with saidorder.
 21. A system for printing identity labels in a healthcaresetting, comprising: a scanner for scanning a patient label; a processorcommunicating patient data stored in a handheld device with a database,the database including patient demographic information related to saidpatient; and a printer in communication with said handheld device,wherein said handheld device instructs said printer to generate anidentity label including patient demographic information if the patientdata in the handheld device has patient demographic informationcorresponding to a patient label scanned by said scanner.